NCT02286765

Ulthera® System for Treating Axillary Hyperhidrosis

Optimization of the Ulthera® System for Treating Axillary Hyperhidrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days following the last treatment. Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.

Detailed description

This study is a prospective, single-center, randomized clinical trial. Up to 20 subjects who are naïve to Ultherapy for treatment of hyperhidrosis will be enrolled and treated at a 2.0mm depth at two different treatment densities (Group A and Group B). Group A will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid, 12 treatment squares, 60 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy. Group B will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid, 12 treatment squares, 40 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy. Gravimetric sweat production measures and starch iodine tests will be completed at baseline, treatment visit #2, and at all follow-ups for all study groups. Digital images of the starch iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained at baseline, each treatment visit, and at all follow-ups for all study groups.

Conditions

• Primary Axillary Hyperhidrosis

Interventions

Type	Name	Description
DEVICE	Ulthera System treatment	Micro-focused ultrasound energy delivered below the surface of the skin

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2014-11-10
• Last updated: 2017-12-14

Locations

1 site across 1 country: United States